K243453 is an FDA 510(k) clearance for the Philips Lumea IPL, a Light Based Over-the-counter Hair Removal (Class II — Special Controls, product code OHT), submitted by Philips Consumer Lifestyle B.V. (Drachten, NL). The FDA issued a Cleared decision on February 10, 2025, 95 days after receiving the submission on November 7, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K243453 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 07, 2024 |
| Decision Date | February 10, 2025 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | OHT — Light Based Over-the-counter Hair Removal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal. |